HemophiliaPhase 3SCOPE HIMNCT05695391

Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery

A Phase 3 study testing Coagulation Factor VIIa (Recombinant) in people with Hemophilia, run by Laboratoire français de Fractionnement et de Biotechnologies at 15 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures. Read more about this study

Who is it for?: Ages 12 to 65 years, men only
Conditions the study is for: Hemophilia
What is being tested?: Coagulation Factor VIIa (Recombinant)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 15 sitesin 6 countries
Study dates: 7 Jun 2024to 7 Jul 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 65 years
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Each patient must meet the following criteria to be enrolled in this study:
be male with a diagnosis of congenital hemophilia A or B of any severity
have one of the following:
current positive inhibitor test BU ≥5 (as confirmed at screening by the institutional lab) or history of high-responding inhibitors (BU ≥5) not further successfully treated by Immune Tolerance Induction OR
a condition precluding the use of FVIII or FIX products to treat or prevent bleeding such as a previous anamnestic response after exposure to factor concentrates or a previous failure to respond to FVIII or FIX concentrates
be ≥12 years to ≤65 years of age on the day of informed consent

Show all 10Show fewer

be scheduled for an elective major surgical procedure as defined in the study protocol (see Table ''Definitions for the specific purpose of Study F7TG2202'')
have Hb ≥ 12 g/dL
be capable of understanding and willing to comply with the conditions of the protocol OR in the case of a patient under the age of legal majority, parent(s)/legal guardian(s) must be capable of understanding and willing to comply with the conditions of the protocol
have read, understood, and provided written informed consent (patient or parent(s)/legal guardian(s) if the patient is minor according to local regulation) and, where applicable according to local regulation, patient's assent if the patient is minor

Who cannot join

Patients who meet any of the following criteria will be excluded from the study.
have any coagulation disorder other than hemophilia A or B
be immunosuppressed (i.e. the patient should not be receiving systemic immunosuppressive medication; CD4+ cell counts at screening should be >200/μL)
known intolerance to EB or any of its excipients
currently receiving immune tolerance induction (ITI) therapy
have a known or suspected allergy or hypersensitivity to rabbits or rabbit proteins

Show all 20Show fewer

have platelet count <100,000/μL
have received an investigational drug within 30 days or within 5 half-lives of that investigational drug, whichever is longer, of the planned first EB administration, or be expected to receive such drug during participation in this study. Patients who have received fitusiran in a clinical study may not participate in this clinical study for 6 months since the last dose and if they have an antithrombin III level not in the normal range at screening.
for patients using emicizumab, have received during the last 6 months or currently receiving a maintenance dosing regimen of emicizumab different from the indicated one ± 10% of approved dose), i.e. different from 1.5 mg/kg once weekly (±10%), 3 mg/kg (±10%) every two weeks or 6 mg/kg (±10%) every four weeks
for patients using emicizumab, currently be any plans, or notes in the patient's medical records that would suggest the need to increase or decrease emicizumab dosing due to antidrug antibodies (ADAs), reduced PK, or coagulation/safety-related issues (e.g. lack of response, or potential/actual thromboembolic concerns, etc)
have a clinically relevant hepatic (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 times the upper limit of normal [ULN]) and/or renal impairment (creatinine >2 times the ULN)
have a history of arterial and/or venous thromboembolic events (such as myocardial infarction, ischemic strokes, transient ischemic attacks, DVT, or PE) within 2 years prior to the planned first dose of LR769, uncontrolled arrhythmia, or current New York Heart Association (NYHA) functional classification score of stages II - IV
have an active malignancy (those with non-melanoma skin cancer are allowed)
have any life-threatening disease or other disease or condition which, according to the investigator's judgment, could imply a potential hazard to the patient, or interfere with the study participation or study outcome (e.g. chronic, unmanaged hepatitis infection)
be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitory properties within one week prior to surgery and for the duration of treatment with EB
have active gastric or duodenal ulcer disease
have received a FVII- or FVIIa-containing product (either plasma derived or recombinant) within 24 hours prior to administration of EB
have a contraindication to antifibrinolytics
have planned combined major surgeries at the same time or have already been enrolled and treated for a previous elective major surgery in the same SCOPE HIM study
be administered pharmacologic thromboprophylaxis within 5 half-lives of that medication before surgery or for the duration of treatment with EB -

Trial locations and contacts

15 sites in 6 countries.

Country

City, postcode or hospital

15 sites in 6 countries

United States5 sites

Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Orthopaedic Institute for Children - Orthopaedic Hemophilia Treatment Center
Los Angeles, California, 90007
M Health Fairview Center for bleeding and Clotting disorders
Minneapolis, Minnesota, 55455
Tulane Univertsity School of Medecine
New Orleans, Louisiana, 70112

Other trials in United States

Turkey (Türkiye)4 sites

Hacettepe Üniversitesi Rektörlüğü Sihhiye
Altındağ, Ankara, 06230
Istanbul Üniversitesi Onkoloji Enstitusu
Fatih, Istanbul, 34093
Acibadem Adana Hospital
Seyhan, Adana, 01130
Karadeniz Teknik Üniversitesi
Trabzon, Trabzon, 61080

Other trials in Turkey (Türkiye)

Malaysia2 sites

Hospital Ampang
Ampang, Selangor Province, 68000
Hospital Queen Elisabeth - Kota Kinabalu
Kota Kinabalu, Sabah Province, 88586

Other trials in Malaysia

Thailand2 sites

Chiang Mai University
Chiang Mai, 50200
Maharaj Nakorn Chiangmai Hospital, Chiangmai University
Chiang Mai, 50200

Other trials in Thailand

Mexico1 site

Hospital Universitario Dr. José Eleuterio González de Nuevo León
Monterrey, Nuevo León, 64460

Other trials in Mexico

South Africa1 site

Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2196

Other trials in South Africa

About this study

Official title: A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures

Conditions: Hemophilia
Being tested: Coagulation Factor VIIa (Recombinant)
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coagulation Factor VIIa (Recombinant)Biological
Eptacog Beta (activated) (EB)

Study groups in NCT05695391
Study group	Role	What they receive
Coagulation Factor VIIa (Recombinant)	Experimental	Not described Receives: Biological: Coagulation Factor VIIa (Recombinant)

What is being measured

The primary outcome is the main question the study is designed to answer.

Eptacog Beta (Activated) (EB) Effectiveness Based on Protocol's Aggregate Score
Successfully treated major procedures defined by a good or excellent global hemostatic response, based on an aggregate score from 3 timepoints (intra-operative, 24h post-operative, 120h post-operative), each individual score depending on comparison between actual and preliminary-communicated expected blood loss and transfusions for a similar patient without bleeding disorder undergoing the same surgical procedure, but also on the use or not of IMP extra-doses or of rescue therapy.
Measured: From surgical wound closure until 120 hours after surgical wound closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 20247 Jul 2025

First posted25 Jan 2023
Study start7 Jun 2024
Primary completion28 May 2025
Study completion7 Jul 2025

Why it stopped: Feasibility considerations - extended timelines to complete recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemophiliaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05695391
Sponsor's protocol ID: F7TG2202
Acronym: SCOPE HIM
Status last verified: Jul 2026
First submitted: 21 Dec 2022
Last updated: 31 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures
ClinicalTrials.gov ID: NCT05695391
Acronym / sponsor ID: SCOPE HIM / F7TG2202
Conditions: Hemophilia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Feasibility considerations - extended timelines to complete recruitment
Enrolment: 2 participants (actual)
Lead sponsor: Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
Study start: 7 Jun 2024 (actual)
Primary completion: 28 May 2025 (actual)
Study completion: 7 Jul 2025 (actual)
First posted: 25 Jan 2023 (actual)
Results: Posted 31 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Coagulation Factor VIIa (Recombinant)	Experimental	Biological: Coagulation Factor VIIa (Recombinant)

Who may qualify

Ages: 12 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

be male with a diagnosis of congenital hemophilia A or B of any severity
have one of the following:
be ≥12 years to ≤65 years of age on the day of informed consent
be scheduled for an elective major surgical procedure as defined in the study protocol (see Table ''Definitions for the specific purpose of Study F7TG2202'')
have Hb ≥ 12 g/dL

Key exclusion criteria (20 listed)

Patients who meet any of the following criteria will be excluded from the study.
have any coagulation disorder other than hemophilia A or B
be immunosuppressed (i.e. the patient should not be receiving systemic immunosuppressive medication; CD4+ cell counts at screening should be >200/μL)
known intolerance to EB or any of its excipients
currently receiving immune tolerance induction (ITI) therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coagulation Factor VIIa (Recombinant)Eptacog Beta (activated) (EB)	Biological	Coagulation Factor VIIa (Recombinant)

Primary outcome

Eptacog Beta (Activated) (EB) Effectiveness Based on Protocol's Aggregate Score
Time frame: From surgical wound closure until 120 hours after surgical wound closure
Successfully treated major procedures defined by a good or excellent global hemostatic response, based on an aggregate score from 3 timepoints (intra-operative, 24h post-operative, 120h post-operative), each individual score depending on comparison between actual and preliminary-communicated expected blood loss and transfusions for a similar patient without bleeding disorder undergoing the same surgical procedure, but also on the use or not of IMP extra-doses or of rescue therapy.

Results and safety

Results posted to the registry on 31 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coagulation Factor VIIa (Recombinant)	2	2

Primary outcome: Eptacog Beta (Activated) (EB) Effectiveness Based on Protocol's Aggregate Score

Time frame: From surgical wound closure until 120 hours after surgical wound closure. Count of participants. Unit: Participants

Measure	Coagulation Factor VIIa (Recombinant) n = 2
Excellent or good rating	1
Moderate or poor rating	1

Population analysed: Full Analysis Set was planned to be used, comprised of all major procedures conducted from patients enrolled into the study who had received at least one dose of study drug with each patient having one treated major procedure. However, as only two patients were enrolled due to study termination caused by feasibility considerations, no population-based analysis was done. Only individual data were recorded.

Adverse events

Time frame: Adverse Events (AEs) were to be collected from the time of signing of the informed consent/assent until resolution or until the follow-up call which was 30 ± 2 days after the last dose of EB, or until early termination, whichever came first. As only 2 patients were effectively enrolled in the study, any AE would have a frequency of at least 50%, thus effectively exceeding the frequency threshold above which other adverse events are reported, therefore all AEs are reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coagulation Factor VIIa (Recombinant)	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Limitations and caveats (from the sponsor): The study was prematurely discontinued due to persistent difficulties in recruiting patients.There was no safety issue or concern. As the study was terminated early, no conclusions can be drawn from this study regarding the efficacy of Eptacog Beta (activated).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemophilia

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miguel ESCOBAR, MD principal investigator

The University of Texas Health Science Center, Houston

15 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Coagulation Factor VIIa (Recombinant) in people with Hemophilia, run by Laboratoire français de Fractionnement et de Biotechnologies at 15 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Turkey (Türkiye), Malaysia, Thailand, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eptacog Beta (Activated) (EB) Effectiveness Based on Protocol's Aggregate Score (time frame: From surgical wound closure until 120 hours after surgical wound closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.